Principal Engineer

Overview

Position Summary:

Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields.

Generally, uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. Maintains a clear overview of a major product development. Makes sound judgments when compromises, necessitated by available time and technical capacity, must be made to meet set objectives. Mentors junior staff.

Key Accountabilities:

Essential Functions:

• Acts as an Individual contributor, core team or technical lead for a specific project or product line.
• Accountable for the completion of assigned deliverables in accordance with approved schedules.
• Authors documentation and participates in activities in support of design control.
• Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals.
• Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, if required by the function.
• Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions.
• Evaluates complex designs or processes, with respect to acceptability, suitability and cost. Recommends preferred design options. Presents trade-off, if required by the function.
• Identifies product defects and able to recognize outliers in results. Able to explain and document product defects and their impact.
• Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
• Technical expertise in more than one or a subject matter expert in at least 1 area.
• Leads without authority & provides technical guidance to engineers and technicians assigned to him/her on a given project. Provides mentoring within or outside of their department.
• Provides technical support for or leads CAPA or complaint investigations.
• Independently generates predictable schedules for activities related to the function, understanding cross‑functional dependencies.

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and drives improvement initiatives and motivates others to implement.
• May be assigned CAPA ownership.

Budget Managed: (if applicable)

• N/A

Internal Networking/Key Relationships:

To be determined based on department needs, to include interactions such as:

• Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technically adept and confident
• Leadership:
  Accountability, Decision Making, Influence, Communication
• Mentoring

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in Engineering, Science or a related field

Experience:

• Twelve years of product development or relevant experience
• Eight to ten years of product development or relevant experience for advanced degrees
• For internal candidate promotion:
  Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired

Additional Skills/Knowledge:

• Language:
  Proficiency in English language required

• Required:
  
  No

• Some domestic and international travel may be required.

The annual base salary range for this role is currently $165,000 to $200,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance‑based bonus.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national…